Cleared Traditional

K942098 - PROSPECT GIARDIA

K942098 is an FDA 510(k) clearance for PROSPECT GIARDIA, manufactured by Alexon, Inc.. The device is a Class 2 Microbiology device with product code MHI cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K942098 · Alexon, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
148d
Days
Class 2
Risk

K942098 is an FDA 510(k) clearance for the PROSPECT GIARDIA. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Alexon, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3220 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alexon, Inc. devices

FDA 510(k) Submission Details - K942098

510(k) Number K942098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1994
Decision Date September 09, 1994
Days to Decision 148 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 102d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHI Device Classification - Class 2, Special Controls

Product Code MHI Giardia Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.